Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 2-year survival proportion from 1) diagnosis and 2) IRE
研究概览
简要总结
This study is a single-arm clinical trial of irreversible electroporation (IRE) for the treatment of unresectable locally advanced pancreatic cancer (LAPC).
The aim of the study is to evaluate the efficacy of IRE in this patient group. A statistical analysis of patient survival will be performed, comparing study participants to historical data from the Danish national database of pancreatic cancer patients.
详细描述
Patients with unresectable LAPC can be included in the study. Prior to inclusion, initial treatment with chemotherapy with or without radiation therapy (RT) is administered to all patients accord to the referring institutions protocol. Some patients will have undergone an attempted resection prior to inclusion. It is expected, that a substantial number of patients are participants in the LAPC-03 protocol (FOLFIRINOX followed by local therapy (resection, RT and/or IRE) in patients with LAPC).
After completion of initial therapy, potential study participants are restaged with a PET-CT scan and serum tumor markers. Patients found on restaging to be free of metastatic disease and without significant primary tumor progression will be candidates for IRE therapy. IRE therapy will be administered not earlier than 2 weeks after completion of initial therapy.
IRE will be done under general anesthesia as an in-patient procedure. Patients will attend study specific visits with PET-CT scan 3, 6, 9, 12, 18 and 24 months post-IRE. Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 15, 18, 21 and 24 months. During this we will monitor pain, quality of life, global functioning and nutritional status.
In patients who, at any time during the study, are assessed as candidates for resection, a more detailed re-evaluation of resectability is performed according to local preferences (e.g. EUS and/or LAP/LUS and/or CT and/or MR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytologically proven adenocarcinoma/carcinoma of the pancreas.
- •Largest tumor diameter ≤4 cm in any plane.
- •>18 years of age.
- •Prior treatment with neoadjuvant chemotherapy for at least 2 months
- •Tumor must be deemed as unresectable at the national pancreatic multidisciplinary team conference after neoadjuvant treatment.
- •Non-progressive disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECiST 1.1) after neoadjuvant treatment.
- •Patients must be able to give informed consent.
排除标准
- •Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound).
- •ASA score >3
- •ECOG performance status >2
- •Pregnancy.
- •Atrial fibrillation.
- •Implanted electronic device e.g. cardiac pacemakers or other electrostimulators.
- •Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE).
- •Signs of severe disease of the bone marrow, kidney or liver during time of treatment. Treatment may be postponed if the disease state is reversible.
- •Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment.
- •Patient is referred from hospital outside of Denmark
结局指标
主要结局
2-year survival proportion from 1) diagnosis and 2) IRE
时间窗: 2 years after the last patient is enrolled
次要结局
- 90-day complication rate and severity (Clavien-Dindo)(90 days after the last patient is enrolled)
- Resection rate(2 years after the last patient is enrolled)
- Quality of life (EORTC QLQ C-30)(Every 3 months for 2 years after the intervention)
- Long term pain perception (m-BPI-SF)(Every 3 months for 2 years after the intervention)
- Progression free survival after IRE(2 years after the last patient is enrolled)
- Median time to dissemination after IRE(2 years after the last patient is enrolled)
- Perioperative pain perception (VAS)(Every week for 1 month after the intervention)
- Median time to local progression after IRE(2 years after the last patient is enrolled)
- Median overall survival from 1) diagnosis and 2) IRE(2 years after the last patient is enrolled)
- ECOG performance status(Every 3 months for 2 years after the intervention)
- Nutritional status assessment (PG-SGA-SF)(Every 3 months for 2 years after the intervention)
研究者
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Professor of surgery, Consultant surgeon, DMSc
Aalborg University Hospital